Intraluminal occlusion devices and methods of blocking the entry of fluid into bodily passages

ABSTRACT

An intraluminal occlusion device includes a frame and an attached covering. The frame includes longitudinal struts having concave and convex portions. The intraluminal occlusion devices can be implanted at an opening to a body vessel, such as a blind passage, to block the entry of fluid into the vessel. Methods of blocking the entry of fluid into bodily passages are also described.

CROSS REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application Ser.No. 61/291,437, filed on Dec. 31, 2009. The entire disclosure of thisrelated application is hereby incorporated into this disclosure.

FIELD

The invention relates generally to the field of medical devices. Moreparticularly, the invention relates to intraluminal occlusion devicesthat can be used to block the entry of fluid into a passage. Theinvention also relates to methods of blocking the entry of fluid intobodily passages.

BACKGROUND

It is sometimes necessary or otherwise desirable to block the entry offluid into a body passage. In some individuals, for example, the leftatrial appendage (LAA), a relatively small, thumb-shaped cavity locatedoff the left atrium between the mitral valve and the left pulmonaryvein, may not contract with enough force to completely expel blood fromthe cavity as the heart contracts. The presence of stagnant blood in theLAA may increase the potential for the formation of blood clots and/orthrombi, which could lead to stroke and other clinical conditions.

Occlusion of the LAA may block the entry of blood into the LAA, therebyeliminating the presence of stagnant blood and reducing the potentialfor stroke and other clinical conditions.

A need exists, therefore, for improved intraluminal occlusion devicesand methods of blocking the entry of fluid into bodily passages.

SUMMARY OF THE DISCLOSURE

Several exemplary intraluminal occlusion devices are described herein.The occlusion devices can be used to block the entry of fluid into abodily passage.

An exemplary intraluminal occlusion device comprises a tubular framehaving a lengthwise axis, a proximal end defining a proximal opening, adistal end defining a distal opening, and a circumferential surfaceextending from the proximal end to the distal end. The frame comprisestwo or more longitudinal struts, each of which has a proximal concaveportion and a distal convex portion. A covering extends over theproximal opening and is attached to the tubular frame.

Another exemplary intraluminal occlusion device comprises a tubularframe having a lengthwise axis, a proximal end defining a proximalopening, a distal end defining a distal opening, and a circumferentialsurface extending from the proximal end to the distal end. Abioremodellable covering is attached to the frame and extends over theproximal opening. A first longitudinal strut has a first proximalconcave portion and a first distal convex portion. The first proximalconcave portion has a first longitudinal midpoint and the first distalconvex portion has a second longitudinal midpoint. A first transverseaxis orthogonally intersects the first proximal concave portion at thefirst longitudinal midpoint and a second transverse axis orthogonallyintersects the first distal convex portion at the second longitudinalmidpoint. The first transverse axis orthogonally intersects thelongitudinal axis of the intraluminal occlusion device.

Another exemplary intraluminal occlusion device comprises a tubularframe having a lengthwise axis, a proximal end defining a proximalopening, a distal end defining a distal opening, and a circumferentialsurface extending from the proximal end to the distal end. Abioremodellable covering is attached to the frame and extends over theproximal opening. A first longitudinal strut has a first proximalconcave portion and a first distal convex portion. The first proximalconcave portion has a first longitudinal midpoint and the first distalconvex portion has a second longitudinal midpoint. A first transverseaxis orthogonally intersects the first proximal concave portion at thefirst longitudinal midpoint and a second transverse axis orthogonallyintersects the first distal convex portion at the second longitudinalmidpoint. The first transverse axis orthogonally intersects thelongitudinal axis of the intraluminal occlusion device while the secondtransverse axis non-orthogonally intersects the longitudinal axis of theintraluminal occlusion device. A barb of a first series of barbs isdisposed on the proximal end of the concave portion of one of thelongitudinal struts and a barb of a second series of barbs is disposedon the distal end of the concave portion of one of the longitudinalstruts.

Methods of blocking the entry of fluid into bodily passages are alsodescribed.

An exemplary method of blocking the entry of fluid into a bodily passagecomprises delivering an intraluminal occlusion device according to theinvention to an opening of the bodily passage into which the entry offluid is to be blocked; positioning the intraluminal occlusion device ata point of treatment such that the proximal concave portions of the oneor more longitudinal struts are adjacent the opening to the bodilypassage being blocked, and such that the distal convex portions aredisposed further within the bodily passage bodily passage being blocked;and anchoring the intraluminal occlusion device at the point oftreatment.

An exemplary method of blocking the entry of fluid into the left atriumappendage of an animal, such as a human or other mammal, comprisesdelivering an intraluminal occlusion device according to the inventionto an opening of the left atrium appendage into which the entry of fluidis to be blocked; positioning the intraluminal occlusion device at apoint of treatment such that the proximal concave portions of the one ormore longitudinal struts are adjacent the opening to the LAA, and suchthat the distal convex portions are disposed further within the LAA;deploying the intraluminal occlusion device from the delivery system atthe point of treatment such that the tissue of the annular opening ofthe LAA contacts the proximal concave portions of the one or morelongitudinal struts and such that the distal convex portions of the oneor more longitudinal struts are disposed within the LAA and in contactwith the tissue of the interior chamber defined by the LAA; and removingthe delivery system from the bodily passage(s) through which it wasnavigated.

Additional understanding of the devices and methods contemplated and/orclaimed by the inventor can be gained by reviewing the detaileddescription of exemplary embodiments, presented below, and thereferenced drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view, partially broken away, of a first exemplaryintraluminal occlusion device.

FIG. 2 is a sectional view of the intraluminal occlusion deviceillustrated in FIG. 1.

FIG. 3 is a sectional view of a left atrial appendage into which theintraluminal occlusion device illustrated in FIG. 1 has been implanted.

FIG. 4 is a sectional view of a second exemplary intraluminal occlusiondevice.

FIG. 5 is a sectional view of a third exemplary intraluminal occlusiondevice.

FIG. 6 is a flowchart representation of an exemplary method of blockingthe entry of fluid into a bodily passage.

FIG. 7 is a flowchart representation of another exemplary method ofblocking the entry of fluid into a bodily passage.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The following description of exemplary embodiments provides illustrativeexamples of that which the inventor regards as his invention. As such,the embodiments discussed herein are merely exemplary in nature and arenot intended to limit the scope of the invention, or its protection, inany manner. Rather, the description of these exemplary embodimentsserves to enable a person of ordinary skill in the relevant art topractice the invention.

FIGS. 1 through 3 illustrate an expandable intraluminal occlusion device100 according to a first embodiment. The occlusion device 100 comprisesa frame 110 and a covering 112 attached to the frame 110 by a pluralityof attachment elements 114.

FIG. 2 illustrates various references lines and points used herein inconnection with describing various aspects of the expandableintraluminal occlusion device 100. The expandable intraluminal occlusiondevice 100 has a longitudinal axis 101 that includes longitudinalmidpoint 103. The expandable intraluminal occlusion device 100 also hasfirst 105 and second 107 transverse axes. These axes 105, 107 do notnecessarily orthogonally intersect the longitudinal axis 101. Thus, asdescribed more fully below, these axes 105, 107 do not necessarilyintersect the longitudinal axis 101 at right angles. A proximal end axis109 includes the proximal end of the frame 112 and orthogonallyintersects the longitudinal axis 101 at proximal axial intersectionpoint 111. Similarly, a distal end axis 113 includes the distal end ofthe frame 112 and orthogonally intersects the longitudinal axis 101 atdistal axial point 115.

The frame 110 advantageously has radially compressed and radiallyexpanded configurations, allowing the frame 110 to be implanted at apoint of treatment within a body vessel by minimally invasivetechniques. For example, the expandable nature of the frame 110 allowsthe intraluminal occlusion device 100 to be navigated through a bodyvessel on a delivery catheter while in a radially compressedconfiguration, and deployed at a point of treatment in a body vessel bytransitioning from the radially compressed configuration to the radiallyexpanded configuration. The transition from the radially compressedconfiguration to the radially expanded configuration can be accomplishedaccording to conventional techniques, such as by removing a constrainingforce or by applying and outwardly-directed expansive force, asappropriate for the type of expandable frame used in an intraluminalocclusion device according to a particular embodiment (see below).

The frame 110 provides a void-filling function to the intraluminalocclusion devices described herein. The frame 110 can optionally provideadditional function to these devices. For example, the frame 110 canprovide a stenting function, i.e., exert a radially outward force on theinterior wall of a vessel in which the intraluminal occlusion device 100is implanted. By including a frame 110 that exerts such a force, anintraluminal occlusion device 100 can provide both a void-filling and astenting function at a point of treatment within a body vessel.Expandable frames are considered advantageous for their ability toprovide this additional stenting function.

The expandable frame 110 can be a self-expandable frame or a frame thatrequires the application of a force to effect expansion, such as aballoon-expandable frame. The structural characteristics of both ofthese types of support frames are known in the art, and are not detailedherein. Each type of expandable frame has advantages and for any givenapplication, one type may be more desirable than the other based on avariety of considerations. For example, in the peripheral vasculature,vessels are generally more compliant and typically experience dramaticchanges in their cross-sectional shape during routine activity.Intraluminal medical devices for implantation in the peripheralvasculature should retain a degree of flexibility to accommodate thesechanges of the vasculature. Accordingly, expandable intraluminalocclusion devices intended for implantation in the peripheralvasculature advantageously include a self-expandable support frame.These support frames, as is known in the art, are generally moreflexible than balloon-expandable support frames following deployment.

If an ability to be delivered to and deployed at a point of treatment ina body vessel by minimally-invasive techniques is not a consideration, anon-expandable frame can be used in an intraluminal occlusion deviceaccording to an embodiment of the invention. For example, a frame formedof plastic, metal, or other suitable material and having little or nocompliance can be used in intraluminal occlusion devices intended to beplaced at a point of treatment using other techniques, such as surgicalplacement techniques.

Suitable frames can be made from a variety of materials and need only bebiocompatible or able to be made biocompatible. Examples of suitablematerials include, without limitation, stainless steel, nickel titanium(NiTi) alloys, e.g., nitinol, other shape memory and/or superelasticmaterials, molybdenum alloys, tantalum alloys, titanium alloys, preciousmetal alloys, nickel chromium alloys, cobalt chromium alloys, nickelcobalt chromium alloys, nickel cobalt chromium molybdenum alloys, nickeltitanium chromium alloys, linear elastic Nitinol wires, polymers, andcomposite materials. Also, resorbable and bioremodellable materials canbe used. As used herein, the term “resorbable” refers to the ability ofa material to be absorbed into a tissue and/or body fluid upon contactwith the tissue and/or body fluid. A number of resorbable materials areknown in the art, and any suitable resorbable material can be used.Examples of suitable types of resorbable materials include resorbablehomopolymers, copolymers, or blends of resorbable polymers. Specificexamples of suitable resorbable materials include poly-alpha hydroxyacids such as polylactic acid, polylactide, polyglycolic acid (PGA), orpolyglycolide; trimethylene carbonate; polycaprolactone; poly-betahydroxy acids such as polyhydroxybutyrate or polyhydroxyvalerate; orother polymers such as polyphosphazines, polyorganophosphazines,polyanhydrides, polyesteramides, polyorthoesters, polyethylene oxide,polyester-ethers (e.g., polydioxanone) or polyamino acids (e.g.,poly-L-glutamic acid or poly-L-lysine). There are also a number ofnaturally derived resorbable polymers that may be suitable, includingmodified polysaccharides, such as cellulose, chitin, and dextran, andmodified proteins, such as fibrin and casein.

Stainless steel and nitinol are currently considered desirable materialsfor use in the support frame due at least to their biocompatibility,shapeability, ready commercial availability, and well-characterizednature. Also, cold drawn cobalt chromium alloys, such as ASTM F562 andASTM F1058 (commercial examples of which include MP35N™ and Elgiloy™,both of which are available from Fort Wayne Metals, Fort Wayne, Ind.;MP35N is a registered trademark of SPS Technologies, Inc. (Jenkintown,Pa., USA); Elgiloy is a registered trademark of Combined Metals ofChicago LLC (Elk Grove Village, Ill., USA)), are currently consideredadvantageous materials for the support frame at least because they arenon-magnetic materials that provide beneficial magnetic resonanceimaging (MRI) compatibility, and avoid MRI artifacts typicallyassociated with some other materials, such as stainless steel.

Suitable frames can also have a variety of shapes and configurations,including braided strands, helically wound strands, ring members,consecutively attached ring members, zig-zag members, tubular members,and frames cut from solid tubes.

Frames for use in the intraluminal occlusion devices described hereincan be formed in a variety of manners. For example, the frame can beformed from one or more wires, such as from lengths of wire having acircular, D-shaped or other suitable cross-sectional configuration.Also, a frame can be cut from a tubular member, such as by cutting adesired pattern of struts from a tubular section of a suitable material.Laser-cutting a frame from a tubular section of nitinol, stainless steelor other material is considered an advantageous process for forming aframe for use in an intraluminal occlusion device according to aparticular embodiment. A solid tubular member can also be used.

Furthermore, no matter the type of frame used in an intraluminalocclusion device according to a particular embodiment, the frame caninclude any suitable arrangement of struts.

In the embodiment illustrated in FIGS. 1 through 3, the frame 110comprises an expandable frame having struts 120 that form a tubularstructure 122 with proximal 124 and distal 126 ends. The frame definesan interior chamber 128 that is in communication with the externalenvironment via spaces between the various struts 120. The frame 110 isa self-expandable frame that includes a plurality of longitudinal struts130 and a plurality of interconnecting struts 132 that individuallyextend between adjacent longitudinal struts 130. The frame 110 alsoincludes a series of barbs 134 adapted to engage adjacent tissue whenthe intraluminal occlusion device 100 is implanted at a point oftreatment within a body vessel.

Each of the longitudinal struts 130 can have any suitable size, shapeand configuration. The longitudinal struts 130 shown for the embodimentillustrated in FIGS. 1 through 3 include structural features that adaptthe intraluminal occlusion device 100 for use in the left atrialappendage and other blind passages that include an annular opening.

As best illustrated in FIG. 2, each of the longitudinal struts 130 inthis embodiment includes a concave portion 140 and a convex portion 142.The concave portion 140 of each longitudinal strut 130 has a proximalend 141 and a distal end 143, and a length 144 that extends along thelongitudinal axis 101 from the proximal axial intersection point 111 toa point on the longitudinal axis 101 that is beyond the midpoint 103 ofthe longitudinal axis 101. In contrast, the convex portion 142 has alength 146 that extends along the longitudinal axis 101 from the distalaxial intersection point 115 to a point on the longitudinal axis 101that is before the midpoint 103. While the illustrated configuration isconsidered advantageous, it is understood that alternative relativeconfigurations of the concave 140 and convex 142 portions of thelongitudinal struts 130 are also contemplated. For example, the convexportion 142 of each longitudinal strut 130 can have a length thatextends along the longitudinal axis 101 from the distal axialintersection point 115 to a point on the longitudinal axis 101 that isbeyond the midpoint 103 of the longitudinal axis 101, giving the concaveportion 140 a length that extends along the longitudinal axis 101 fromthe proximal axial intersection point 111 to a point on the longitudinalaxis 101 that is before the midpoint 103.

As best illustrated in FIG. 2, the first transverse axis 105orthogonally intersects longitudinal strut 130 at the longitudinalmidpoint 145 of the concave portion 140 and the second transverse axis107 orthogonally intersects longitudinal strut 130 at the longitudinalmidpoint 147 of the convex portion 142. In the first exemplaryembodiment, the first transverse axis 105 also orthogonally intersectsthe longitudinal axis 101 when the frame 112 is in its fully expandedconfiguration (i.e., its resting state). The second longitudinal axis107, however, intersects that longitudinal axis 101 in a non-orthogonalmanner (i.e., not at ninety degrees). FIG. 4 illustrates an alternativeembodiment in which the intraluminal occlusion device 100′ includesfirst 105′ and second 107′ transverse axes that orthogonally intersectthe longitudinal strut 130′ at the longitudinal midpoints 145′, 147′ ofthe concave 140′ and convex 142′ portions, respectively, and that eachorthogonally intersect the longitudinal axis 101′.

Each of these arrangements of the concave 140 and convex 142 portions ofthe longitudinal struts 130 has expected advantages, and a skilledartisan will be able to determine an appropriate arrangement for anexpandable intraluminal occlusion device according to a particularembodiment based on various considerations. For example, the arrangementillustrated for the second exemplary embodiment (FIG. 4) is expected toconfer an enhanced anchoring ability onto the frame 112, which may bebeneficial in expandable intraluminal occlusion devices intended to beused in vessels within which it is relatively difficult to anchor adevice immediately following deployment. This arrangement might also bebeneficial in expandable intraluminal occlusion devices that lack acovering that contributes to the overall anchoring ability of the device(i.e., an expandable intraluminal occlusion device that includes acovering that resists tissue ingrowth, etc.).

While the concave 140 and convex 142 portions of the longitudinal struts130 are illustrated as being directly adjacent each other, i.e., sharingcommon transition point 148, the two portions 140, 142 can be separatedby another portion of the longitudinal strut 130, such as a linear orother curvilinear portion of the strut 130.

Any suitable number and arrangement of longitudinal struts 130 can beused in an intraluminal occlusion device according to a particularembodiment. To provide desirable structural properties, it is consideredadvantageous to include at least two longitudinal struts 130. It isconsidered particularly advantageous to include three or morelongitudinal struts 130. As best illustrated in FIG. 1, an arrangementthat positions three or more longitudinal struts 130 equidistant fromthe longitudinal axis 101 of the intraluminal occlusion device 100 isconsidered advantageous. In the embodiment illustrated in FIGS. 1through 3, four longitudinal struts 130 are positioned equidistant fromthe longitudinal axis 101 and are evenly spaced about a circumference ona plane that orthogonally intersects the longitudinal axis 101.

Each of the interconnecting struts 132 in the embodiment illustrated inFIGS. 1 through 3 spans the space between immediately adjacentlongitudinal struts 130. Adjacent interconnecting struts 132 intersecteach other to form a crossing pattern. While linear interconnectingstruts 132 are illustrated in the figures, other configurations can beused, including curvilinear struts, angulated struts, and struts withtapers, bends, fillets, and/or other structural features.

As best illustrated in FIG. 2, the proximal end 124 of the frame 112includes curvilinear end struts 150 that extend between longitudinalstruts 130. The end struts 150 define a concave proximal end 152 towhich a portion of the covering 112 can be attached. Any suitablenumber, shape and configuration of struts can be used to form theconcave proximal end 152 of the frame 110.

The inclusion of the concave proximal end 152 on the frame 110 isconsidered advantageous at least because it confers a concave proximalend onto the intraluminal occlusion device 100 once the covering 112 isattached to the frame 110. The covering 112 can be attached to thecurvilinear end struts 150 so that the exterior surface of the coveringfollows the curvilinear surface defined by the curvilinear end struts150, conferring a inward directed bowl-shape onto the proximal end ofthe expandable intraluminal occlusion device 100. This overall structurefor the occlusion device 100 is considered advantageous at least becauseit provides a curvilinear surface that is expected to deflect fluid flowfollowing implantation of the occlusion device 100 in a body vessel. Acurvilinear surface is expected to minimize fluid impingement on theproximal end of the expandable intraluminal occlusion device 100, whichmay reduce or minimize the potential for clotting or other consequencesfollowing implantation of the occlusion device 100 in a blood-containingenvironment.

In an alternative embodiment, illustrated in FIG. 5, the intraluminalocclusion device 100″ includes a covering 112″ that is drawn taughtacross an opening defined by the proximal end 124″ of the frame 110″.This can be accomplished by including linear or substantially linearstruts at the proximal end of the frame 110″ and attaching the coveringto these struts, by omitting struts across the proximal end 124″(leaving an opening) and positioning the cover 112″ across the opening,or by leaving the covering unattached to curvilinear end struts, such ascurvilinear end struts 150 of the embodiment illustrated in FIGS. 1through 3. This arrangement might provide some “give” to the covering,which may aid in the flushing of fluid away from the proximal end of theocclusion device 100″.

In contrast to the proximal end of the frame 110, the distal end 126 ofthe frame 110 in the first exemplary embodiment illustrated in FIGS. 1through 3 is substantially flat. The frame 110 can include structuralmembers that provide a flat surface on the distal end 126 or, as bestillustrated in FIG. 1, the distal end 126 can simply comprise an opening160. The covering 112 is placed across the opening 160 to provide a flatsection 162 that is adapted to contact an opposing wall of the vesselinto which the intraluminal occlusion device 100 is implanted. Thisstructural configuration is considered advantageous at least because theflat section 162 of the covering 112 is expected to provide substantialsurface area that can contribute to the overall contact between thecovering 112 and the vessel wall, which may facilitate anchoring of theocclusion device following deployment. This is believed to beparticularly advantageous in embodiments that include a bioremodellablecovering because the ability of these coverings to integrate withsurrounding tissue during the remodelling process is affected by theextent of surface-to-surface contact between the covering and thetissue.

The frame 110 of this embodiment also includes a series of barbs 134.While considered optional, inclusion of the barbs 134 is consideredadvantageous at least because they facilitate anchoring of theintraluminal occlusion device 100 in a body vessel following deployment.Any suitable barb structure can be used, including barbs integrallyformed by the frame 110, separately attached barb members, and microbarbstructures.

As best illustrated in FIG. 2, the barbs 134 of the first exemplaryintraluminal occlusion device include first 170 and second 172 series ofbarbs. Each barb of the first series of barbs 170 is disposed on theproximal end 141 of the concave portion 140 of a longitudinal strut 130and extends away from the longitudinal strut and toward the firsttransverse axis 105. Similarly, each barb of the second series of barbs172 is disposed on the distal end 143 of the concave portion 140 of alongitudinal strut 130 and extends away from the longitudinal strut 130and toward the first transverse axis 105.

This arrangement of barbs is considered particularly advantageous forinclusion in intraluminal occlusion devices intended for use in blindpassages, such as the left atrial appendage, that have an annularopening from another vessel.

FIG. 3 illustrates the intraluminal occlusion device 100 implanted in aleft atrial appendage (LAA) 200. The LAA 200 has a tissue wall 202 thatdefines a blind passage 204. A proximal end 206 defines an annularopening 208 while the distal end 210 is closed by the tissue wall 202.

The intraluminal occlusion device 100 is disposed within the LAA 200such that the portion 212 of the tissue wall 202 that defines theannular opening 208 is in contact with the concave portions 140 of thelongitudinal struts 130 of the intraluminal occlusion device 100. Barbsof the first 170 and second 172 of barbs extend into the portion 212 ofthe tissue wall 202 that defines the annular opening 208. Portions 214of the tissue wall 202 that are distal to the portion 212 that definesthe annular opening 208 are in contact with the convex portions 142 ofthe longitudinal struts 130 of the intraluminal occlusion device 100.This structural arrangement and relationship between the intraluminalocclusion device 100 and the LAA 200 is expected to provide suitableanchoring of the device 100.

FIG. 3 illustrates the curvilinear proximal end 124 of the intraluminalocclusion device 100 relative to the LAA 200. The curvilinear proximalend 124 provides an inward bowl-shaped surface relative to thesubstantially linear surface provided by the portion 212 of the tissuewall 202 that defines the annular opening 208. As described above, thepresence of the inward bowl-shaped surface is expected to providebeneficial performance characteristics when the device 100 is implantedin this manner.

As indicated above, the frame 110 defines an interior chamber 128. Inthe illustrated intraluminal occlusion device 100, the attached covering112 separates the interior chamber 128 from the external environment.

A wide variety of coverings is known in the medical technology arts, andany suitable covering can be used in an expandable intraluminalocclusion device according to a particular embodiment. The covering needonly be able to be attached or otherwise connected to the expandableframe as described herein.

The covering comprises a section of material, such as a sheet, that isattached to the frame 110. The covering can be formed of any suitablematerial, and is advantageously biocompatible or able to be renderedbiocompatible. The material can advantageously comprise a flexiblematerial. Examples of suitable materials for the covering includenatural materials, synthetic materials, and combinations of natural andsynthetic materials. Examples of suitable natural materials includeextracellular matrix (ECM) materials, such as small intestine submucosa(SIS), and other bioremodellable materials, such as bovine pericardium.Other examples of ECM materials that can be used include stomachsubmucosa, liver basement membrane, urinary bladder submucosa, tissuemucosa, and dura mater. Examples of suitable synthetic materials includepolymeric materials, such as expanded polytetrafluoroethylene andpolyurethane. ECM materials are particularly well-suited materials foruse in the covering, at least because of their abilities to remodel andbecome incorporated into adjacent tissues, facilitating anchoring of anexpandable intraluminal occlusion device at a point of treatment in abody vessel. These materials can provide a scaffold onto which cellularin-growth can occur, eventually allowing the material to remodel into astructure of host cells. It is noted that two or more differentmaterials can be used to form the covering. For example, abioremodellable material can be used to form a portion of the coveringthat extends along the circumferential wall of the tubular frame, whicha non-thrombogenic, substantially non-thrombogenic, or relatively lessthrombogenic material, such as a synthetic material, can be used to fora portion of the covering that extends across the proximal end of thedevice. Such a covering is expected to be advantageous at least becausethe first portion can facilitate anchoring of the device and the secondportion can facilitate deflection of blood or other fluid from theexposed proximal end of the device.

The covering 112 can be attached to the frame 110 in any suitable mannerand using any suitable means for attaching a covering to a frame, suchas sutures, clips, and other mechanical attachment elements.Alternatively, bonding agents and/or techniques can be used, such asadhesives, heat sealing, tissue welding, and cross-linking. Furthermore,direct attachment of the covering to the expandable frame can be used.For example, the struts of the frame can be woven through the coveringto create an attachment. Also, the frame can be embedded within thecovering, such as by dipping and spraying a polymeric material onto theframe to form an attached covering. The specific manner in which aparticular covering is attached to an intraluminal occlusion deviceaccording to a particular embodiment will depend at least upon thematerials used in the covering and the expandable frame.

In the embodiment illustrated in FIGS. 1 through 3, the covering 112comprises a sheet of bioremodellable material that is attached to theexpandable frame 110 by a series of sutures 180 that pass through thethickness of the covering and around one or more struts 120 of the frame110. In this first exemplary embodiment, the covering 112 extends overthe entire frame 100, including the first 124 and second 126 ends, suchthat there is no direct communication between the interior chamber 128and the external environment.

FIG. 6 illustrates a flow chart representation of a first exemplarymethod 300 of blocking the entry of fluid into a bodily passage. A firststep 302 comprises delivering an intraluminal occlusion device accordingto the invention to an opening of the bodily passage into which theentry of fluid is to be blocked. In this exemplary method, the occlusiondevice includes one or more longitudinal struts, each having a proximalconcave portion and a distal convex portion. The delivering step can beaccomplished using minimally invasive and/or surgical techniques, andcan be direct or through another body vessel that includes an opening tothe bodily passage being blocked. If minimally-invasive techniques areused, the delivering step can include navigated an appropriate deliverysystem containing the occlusion device through the bodily passage beingblocked, through another bodily passage that provides access to thebodily passage being blocked, or through another suitable route.

Another step 304 comprises positioning the intraluminal occlusion deviceat a point of treatment such that the proximal concave portions of theone or more longitudinal struts are adjacent the opening to the bodilypassage being blocked, and such that the distal convex portions aredisposed further within the bodily passage bodily passage being blocked.

Another step 306 comprises anchoring the intraluminal occlusion deviceat the point of treatment. For expandable intraluminal occlusiondevices, the anchoring step can be accomplished by deploying theintraluminal occlusion device from an appropriate delivery system. Forsurgically placed occlusion devices, anchoring can also includeattaching the device to the bodily passage, such as with sutures, clips,or other suitable attachment members.

An optional step 308 comprises removing the delivery system from thebodily passage(s) through which it was navigated, if a delivery systemwas used.

FIG. 7 illustrates a flow chart representation of an exemplary method400 of blocking the entry of fluid into the left atrium appendage (LAA)of an animal, such as a human or other mammal.

A first step 402 comprises delivering an intraluminal occlusion deviceaccording to the invention to an opening of the LAA into which the entryof fluid is to be blocked. In this exemplary method, the occlusiondevice includes one or more longitudinal struts, each having a proximalconcave portion and a distal convex portion. The occlusion deviceincludes an expandable frame and is provided on a delivery system. Inthis exemplary method, the delivery system is navigated through one ormore body vessels providing access to the LAA.

Another step 404 comprises positioning the intraluminal occlusion deviceat a point of treatment such that the proximal concave portions of theone or more longitudinal struts are adjacent the opening to the LAA, andsuch that the distal convex portions are disposed further within theLAA.

Another step 406 comprises deploying the intraluminal occlusion devicefrom the delivery system at the point of treatment such that the tissueof the annular opening of the LAA contacts the proximal concave portionsof the one or more longitudinal struts and such that the distal convexportions of the one or more longitudinal struts are disposed within theLAA and in contact with the tissue of the interior chamber defined bythe LAA.

Another step 408 comprises removing the delivery system from the bodilypassage(s) through which it was navigated.

The foregoing detailed description provides exemplary embodiments of theinvention and includes the best mode for practicing the invention. Thedescription and illustration of embodiments is intended only to provideexamples of the invention, and not to limit the scope of the invention,or its protection, in any manner.

I claim:
 1. An intraluminal occlusion device having a longitudinal axis,comprising: a tubular frame having a proximal end defining a proximalopening, a distal end defining a distal opening, and a circumferentialsurface extending from the proximal end to the distal end, the framecomprising two or more longitudinal struts and a plurality ofinterconnecting struts extending between adjacent longitudinal struts,each of the longitudinal struts having a proximal concave portion and adistal convex portion disposed within a plane that includes saidlongitudinal axis; and a covering extending over the proximal openingand attached to the tubular frame; wherein a first longitudinal struthas a first proximal concave portion and a first distal convex portion;wherein the first proximal concave portion has a first longitudinalmidpoint and the first distal convex portion has a second longitudinalmidpoint; wherein a first transverse axis orthogonally intersects thefirst proximal concave portion at the first longitudinal midpoint;wherein a second transverse axis orthogonally intersects the firstdistal convex portion at the second longitudinal midpoint; wherein thefirst transverse axis orthogonally intersects said longitudinal axis ofsaid intraluminal occlusion device; and wherein the second transverseaxis non-orthogonally intersects said longitudinal axis of saidintraluminal occlusion device.
 2. The intraluminal occlusion device ofclaim 1, wherein the tubular frame comprises an expandable frame havingradially compressed and radially expanded configurations.
 3. Theintraluminal occlusion device of claim 2, wherein the tubular framecomprises a self-expandable frame.
 4. The intraluminal occlusion deviceof claim 2, wherein the tubular frame requires the input of an expansiveforce to transition from the radially compressed configuration to theradially expanded configuration.
 5. The intraluminal occlusion device ofclaim 2, wherein the tubular frame is formed from one or more wires. 6.The intraluminal occlusion device of claim 2, wherein the tubular frameis cut from a tubular member.
 7. The intraluminal occlusion device ofclaim 2, wherein the tubular frame comprises stainless steel.
 8. Theintraluminal occlusion device of claim 2, wherein the tubular framecomprises nitinol.
 9. The intraluminal occlusion device of claim 1,wherein a first longitudinal strut has a first proximal concave portionand a first distal convex portion; wherein the first proximal concaveportion has a first length that extends along said longitudinal axis ofsaid intraluminal occlusion device and the first distal convex portionhas a second length that extends along said longitudinal axis of saidintraluminal occlusion device; and wherein the first length is greaterthan the second length.
 10. The intraluminal occlusion device of claim1, wherein the covering comprises a bioremodellable material.
 11. Theintraluminal occlusion device of claim 10, wherein the coveringcomprises an extracellular matrix material.
 12. The intraluminalocclusion device of claim 11, wherein the covering comprises smallintestine submucosa.
 13. The intraluminal occlusion device of claim 1,wherein the covering extends over the circumferential surface defined bythe tubular frame.
 14. The intraluminal occlusion device of claim 13,wherein the covering extends over the distal opening.
 15. Theintraluminal occlusion device of claim 1, wherein the tubular frameincludes one or more barbs disposed on a concave portion of at least oneof the longitudinal struts.
 16. The intraluminal occlusion device ofclaim 1, wherein the proximal concave portion of each of thelongitudinal struts has a concave portion proximal end and a concaveportion distal end; further comprising first and second series of barbs,each barb of the first series of barbs disposed on the concave portionproximal end of one of the longitudinal attachment struts and each barbof the second series of barbs disposed on the concave portion distal endof one of the longitudinal attachment struts; wherein each barb of thefirst and second series of barbs extends away from the one of thelongitudinal attachment struts and radially outward with respect to saidlongitudinal axis of said intraluminal occlusion device.
 17. Anintraluminal occlusion device having a longitudinal axis, comprising: atubular frame having a proximal end defining a proximal opening, adistal end defining a distal opening, and a circumferential surfaceextending from the proximal end to the distal end, the frame comprisingtwo or more longitudinal struts; and a bioremodellable covering attachedto the tubular frame and extending over the proximal opening; wherein afirst longitudinal strut of the two or more longitudinal struts has afirst proximal concave portion and a first distal convex portiondisposed within a plane that includes said longitudinal axis, the firstproximal concave portion having a first longitudinal midpoint and thefirst distal convex portion having a second longitudinal midpoint;wherein a first transverse axis orthogonally intersects the firstproximal concave portion at the first longitudinal midpoint and a secondtransverse axis orthogonally intersects the first distal convex portionat the second longitudinal midpoint; and wherein the first transverseaxis orthogonally intersects said longitudinal axis of said intraluminalocclusion device.
 18. An intraluminal occlusion device having alongitudinal axis, comprising: a tubular frame having a proximal enddefining a proximal opening, a distal end defining a distal opening, anda circumferential surface extending from the proximal end to the distalend, the frame comprising two or more longitudinal struts; abioremodellable covering attached to the tubular frame and extendingover the proximal opening; a first series of barbs; and a second seriesof barbs; wherein a first longitudinal strut of the two or morelongitudinal struts has a first proximal concave portion and a firstdistal convex portion disposed within a plane that includes saidlongitudinal axis, the first proximal concave portion having a firstlongitudinal midpoint and the first distal convex portion having asecond longitudinal midpoint; wherein a first transverse axisorthogonally intersects the first proximal concave portion at the firstlongitudinal midpoint and a second transverse axis orthogonallyintersects the first distal convex portion at the second longitudinalmidpoint; wherein the first transverse axis orthogonally intersects saidlongitudinal axis of said intraluminal occlusion device and the secondtransverse axis non-orthogonally intersects said longitudinal axis ofsaid intraluminal occlusion device; wherein the proximal concave portionof each of the two or more longitudinal struts has a concave portionproximal end and a concave portion distal end; wherein each barb of thefirst series of barbs is disposed on the concave portion proximal end ofone of the two or more longitudinal attachment struts and extends awayfrom the longitudinal attachment strut and toward the first transverseaxis; and wherein each barb of the second series of barbs is disposed onthe concave portion distal end of one of the two or more longitudinalattachment struts and extends away from the longitudinal attachmentstrut and toward the first transverse axis.